Provider Briefing: The Depo-Testosterone Shortage in 2026

The Testosterone Cypionate shortage has been one of the most persistent controlled-substance supply disruptions in the United States. For providers who prescribe Depo-Testosterone — whether for hypogonadism management, gender-affirming hormone therapy, or delayed puberty — the shortage creates real clinical challenges: disrupted treatment continuity, patient frustration, and increased administrative burden.

This article provides a concise, evidence-based overview of the current shortage landscape, its clinical implications, and actionable strategies for managing your patients through ongoing supply constraints.

Shortage Timeline

Testosterone Cypionate injection first appeared on the FDA Drug Shortage Database around 2018–2019. Key milestones include:

• 2018–2019: Initial reports of intermittent supply disruptions, primarily affecting the 100 mg/mL concentration.
• 2020–2021: COVID-19 exacerbated supply chain vulnerabilities. Increased demand from telehealth TRT prescribing coincided with manufacturing disruptions across sterile injectable producers.
• 2022–2023: Persistent shortages reported across multiple manufacturers. DEA production quotas increasingly cited as a limiting factor as prescription volumes continued to grow.
• 2024–2025: FDA added cardiovascular boxed warning to all testosterone products following TRAVERSE trial data. Some stabilization in generic supply, but regional shortages persisted.
• 2026 (current): Supply remains intermittent. The 200 mg/mL concentration is generally more available than 100 mg/mL. Multiple generic manufacturers (Hikma, Sun Pharma, Teva, Pfizer) are active, but supply-demand imbalance continues.

Prescribing Implications

The shortage has several practical implications for prescribers:

Continuity of Therapy

Testosterone Cypionate interruptions can cause symptomatic testosterone withdrawal — fatigue, mood changes, decreased libido, and regression of desired effects in gender-affirming therapy patients. Unlike some medications that can be held temporarily, gaps in testosterone therapy are clinically meaningful for many patients.

Boxed Warning Considerations

As of 2024–2025, all testosterone products carry an FDA boxed warning regarding the risk of major adverse cardiovascular events (MACE), including myocardial infarction, stroke, and cardiovascular death. This was based on data from the TRAVERSE trial and post-marketing surveillance. While this doesn't change first-line treatment for documented hypogonadism, it underscores the importance of:

• Confirming the diagnosis with two morning testosterone levels below 300 ng/dL
• Discussing cardiovascular risk with patients, especially those with pre-existing CVD
• Monitoring hematocrit (target below 54%) to mitigate polycythemia-related thrombotic risk

Controlled Substance Regulations

Testosterone Cypionate is a Schedule III controlled substance. Prescribers should be aware that:

• DEA production quotas limit annual manufacturing volumes
• Prescriptions allow up to 5 refills within 6 months
• State-level regulations on controlled substance prescribing (e.g., PDMP checks) apply
• Telehealth prescribing of Schedule III substances is subject to evolving federal and state rules, particularly following post-COVID policy changes

Current Availability Picture

Supply varies significantly by region, pharmacy type, and concentration:

• 200 mg/mL (10 mL vial): Most widely available. Generic versions from multiple manufacturers are generally in stock at independent and specialty pharmacies.
• 100 mg/mL (10 mL vial): More frequently out of stock. Consider dose adjustments to use the 200 mg/mL concentration when possible.
• 1 mL single-dose vials: Sporadically available. Multi-dose vials are more reliably stocked.
• Chain vs. independent pharmacies: Independent pharmacies and specialty/compounding pharmacies often have better access to controlled substance supply from wholesalers.

Real-time availability can be checked through tools like Medfinder for Providers, which allows pharmacy-level stock searching to help you direct patients to pharmacies that currently have supply.

Cost and Access Considerations

Understanding the cost landscape helps manage patient expectations and reduce barriers to adherence:

• Generic Testosterone Cypionate (cash price): $30–$80 for a 10 mL vial (200 mg/mL) with discount cards
• Brand Depo-Testosterone: $150–$350 per vial without insurance
• Insurance coverage: Most commercial plans and Medicare Part D cover generic Testosterone Cypionate with prior authorization. Documentation requirements typically include two morning testosterone levels below 300 ng/dL and clinical symptoms.
• Prior authorization tips: Submit labs and clinical notes proactively. Some plans also require documentation of the specific indication (primary vs. secondary hypogonadism).

For patients with financial barriers, refer to our guide on helping patients save money on Depo-Testosterone.

Tools and Resources for Providers

Several tools can help streamline the process of getting patients their medication:

Medfinder for Providers

Medfinder offers real-time pharmacy stock searching. You and your staff can check which nearby pharmacies have Testosterone Cypionate in stock before sending the prescription, reducing callbacks and patient frustration.

FDA Drug Shortage Database

The FDA Drug Shortage Database provides official shortage status and estimated resolution dates when available. Check periodically for updates on testosterone products.

Alternative Prescribing

When Testosterone Cypionate is unavailable, consider these evidence-based alternatives:

• Testosterone Enanthate (Delatestryl): Most interchangeable option. Same dosing, similar pharmacokinetics. Uses sesame oil (vs. cottonseed oil).
• Testosterone Undecanoate (Aveed): Long-acting IM injection every 10 weeks. Requires REMS enrollment and in-office administration with 30-minute observation. Good option for adherence-challenged patients.
• Testosterone Gel (AndroGel, generic): Daily topical application. Eliminates injection-related barriers but requires counseling on secondary transfer risk.
• Testosterone Pellets (Testopel): Subcutaneous implant every 3–6 months. Requires in-office procedure but provides excellent compliance.

Looking Ahead

Several factors may improve the supply situation in the medium term:

• Additional generic ANDA approvals may bring new manufacturers online
• DEA quota review processes may better account for documented demand increases
• Compounding pharmacy access continues to expand for testosterone preparations
• Subcutaneous dosing protocols using lower volumes may allow patients to use smaller vials or partial fills more effectively

However, as long as testosterone prescribing volumes continue to rise and controlled substance production caps remain, intermittent supply disruptions are likely to persist.

Final Thoughts

The Testosterone Cypionate shortage requires proactive management from prescribers. Build pharmacy relationships, stay informed about supply trends, educate your clinical staff on alternatives, and leverage tools like Medfinder to minimize disruption to your patients' therapy.

For a practical workflow guide, see How to Help Your Patients Find Depo-Testosterone in Stock. For the patient-facing perspective, share our 2026 patient shortage update with your patients.